Evidence map›Paper›PMID 26414435›Full record

Trial reportAmerican journal of hematology2015

Prevention of conversion to abnormal transcranial Doppler with hydroxyurea in sickle cell anemia: A Phase III international randomized clinical trial.

Jane S Hankins, Mary Beth McCarville, Angela Rankine-Mullings, Marvin E Reid, Clarisse L C Lobo, Patricia G Moura, Susanna Ali, Deanne P Soares, Karen Aldred, Dennis W Jay and 7 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in American journal of hematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01531387 (Sparing Conversion to Abnormal TCD Elevation), which is not on this map. Cited by 51 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 8 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01531387 phase3terminatednot on this map

Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III Clinical Trial to Compare Standard Care (Observation) With Alternative Therapy (Hydroxyurea) for Reducing the Risk of Converting to an Abnormal TCD Velocity in Children With Sickle Cell Anemia and Conditional Pre-treatment TCD Velocities.

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2012 to 2014Enrolled38ConditionsSickle Cell AnemiaArmsHydroxyurea
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 8 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022
    Pooled it
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  6. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  7. Pooled it
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  9. Trial
  10. Trial
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  12. Trial
  13. Trial
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  17. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 3 countries.

Jane S HankinsDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee.
Mary Beth McCarvilleDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee.
Angela Rankine-MullingsSickle Cell Unit, Tropical Medicine Research Institute (TMRI), University of the West Indies, Kingston, Jamaica.
Marvin E ReidSickle Cell Unit, Tropical Medicine Research Institute (TMRI), University of the West Indies, Kingston, Jamaica.
Clarisse L C LoboInstituto De Hematologia Arthur Siqueira Cavalcanti (HEMORIO), Rio De Janeiro, Brazil.
Patricia G MouraInstituto De Hematologia Arthur Siqueira Cavalcanti (HEMORIO), Rio De Janeiro, Brazil.
Susanna AliSickle Cell Unit, Tropical Medicine Research Institute (TMRI), University of the West Indies, Kingston, Jamaica.
Deanne P SoaresSickle Cell Unit, Tropical Medicine Research Institute (TMRI), University of the West Indies, Kingston, Jamaica.
Karen AldredSickle Cell Unit, Tropical Medicine Research Institute (TMRI), University of the West Indies, Kingston, Jamaica.
Dennis W JayDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee.
Banu AygunDivision of Pediatric Hematology/Oncology and Stem Cell Transplantation, Cohen Children's Medical Center of New York, New Hyde Park, New York.
John BennettWake Forest University School of Medicine, Winston-Salem, North Carolina.
Guolian KangDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee.
Jonathan C GoldsmithNational Heart Lung and Blood Institute, Bethesda, Maryland.
Matthew P SmeltzerDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee.
James M BoyettDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee.
Russell E WareDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
St. Jude Children's Research Hospital · USUniversity of the West Indies · JMHemorio · BRCincinnati Children's Hospital Medical Center · USCohen Children's Medical Center · USNational Heart Lung and Blood Institute · USUniversity of the West Indies System · JMWake Forest University · US

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
Sparing Conversion to Abnormal TCD ElevationR01HL098239 · NHLBI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI WARE, RUSSELL E · 2010 to 2014
$2.4M
NCI NIH HHS P30 CA021765NHLBI NIH HHS 5R01HL098239NHLBI NIH HHS R01 HL098239
6 · The paper itself

Abstract

Children with sickle cell anemia (SCA) and conditional transcranial Doppler (TCD) ultrasound velocities (170-199 cm/sec) may develop stroke. However, with limited available clinical data, the current standard of care for conditional TCD velocities is observation. The efficacy of hydroxyurea in preventing conversion from conditional to abnormal TCD (≥200 cm/sec), which confers a higher stroke risk, has not been studied prospectively in a randomized trial. Sparing Conversion to Abnormal TCD Elevation (SCATE #NCT01531387) was a National Heart, Lung, and Blood Institute-funded Phase III multicenter international clinical trial comparing alternative therapy (hydroxyurea) to standard care (observation) to prevent conversion from conditional to abnormal TCD velocity in children with SCA. SCATE enrolled 38 children from the United States, Jamaica, and Brazil [HbSS (36), HbSβ(0) -thalassemia (1), and HbSD (1), median age = 5.4 years (range, 2.7-9.8)]. Because of the slow patient accrual and administrative delays, SCATE was terminated early. In an intention-to-treat analysis, the cumulative incidence of abnormal conversion was 9% (95% CI = 0-35%) in the hydroxyurea arm and 47% (95% CI = 6-81%) in observation arm at 15 months (P = 0.16). In post hoc analysis according to treatment received, significantly fewer children on hydroxyurea converted to abnormal TCD velocities when compared with observation (0% vs. 50%, P = 0.02). After a mean of 10.1 months, a significant change in mean TCD velocity was observed with hydroxyurea treatment (-15.5 vs. +10.2 cm/sec, P = 0.02). No stroke events occurred in either arm. Hydroxyurea reduces TCD velocities in children with SCA and conditional velocities.

Indexed as

Anemia, Sickle CellAntineoplastic AgentsChildChild, PreschoolFemaleHumansHydroxyureaMaleUltrasonography, Doppler, TranscranialAntineoplastic AgentsHydroxyurea

Identifiers

PMID26414435
PMCPMC4715740
OpenAlexW2178321006

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.